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Monoclonal Antibodies

IOV-4001 for Melanoma and Lung Cancer

Phase 1 & 2
Recruiting
Research Sponsored by Iovance Biotherapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be assessed as having at least one resectable lesion.
Participants who have received specific previous therapy based on their cohort.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 1 year or depending on when the recommended phase 2 dose is determined
Awards & highlights

Study Summary

This trial will test a new cancer treatment called IOV-4001 on people with melanoma or NSCLC that has spread and can't be removed by surgery. They will be measuring how effective and safe it is.

Who is the study for?
Adults with advanced melanoma or non-small-cell lung cancer (NSCLC) that can't be surgically removed. They must have had certain prior treatments, good organ function, and no untreated brain metastases or recent live vaccines. Participants need a measurable lesion for the study and agree to use effective birth control.Check my eligibility
What is being tested?
The trial is testing IOV-4001 infusion's effectiveness and safety in treating unresectable/metastatic melanoma or advanced NSCLC. It will involve adults who meet specific health criteria and have received previous therapies relevant to their cancer stage.See study design
What are the potential side effects?
While not explicitly listed here, side effects may include typical reactions to infusions such as pain at the injection site, fever, chills, nausea, fatigue, allergic reactions; organ inflammation due to immune response; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have at least one tumor that can be surgically removed.
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I have received specific treatments based on my group assignment.
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My organs are functioning well.
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I have been diagnosed with advanced melanoma or non-small cell lung cancer.
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I am fully active or can carry out light work.
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I have been diagnosed with advanced melanoma or non-small cell lung cancer.
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I have received platinum-based chemotherapy.
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I have at least one tumor that can be measured and was removed for a specific treatment.
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I am fully active or restricted in physically strenuous activity but can do light work.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year or depending on when the recommended phase 2 dose is determined
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year or depending on when the recommended phase 2 dose is determined for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 2: Objective Response Rate (ORR)
Phase I: Safety of IOV-4001
Secondary outcome measures
CR Rate
Disease Control Rate (DCR)
Duration of Response (DOR)
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2Experimental Treatment1 Intervention
Participants with Stage III or IV non-small-cell lung cancer
Group II: Cohort 1Experimental Treatment1 Intervention
Participants with unresectable or metastatic melanoma

Find a Location

Who is running the clinical trial?

Iovance Biotherapeutics, Inc.Lead Sponsor
20 Previous Clinical Trials
1,643 Total Patients Enrolled
Iovance Biotherapeutics Study TeamStudy DirectorIovance Biotherapeutics
2 Previous Clinical Trials
840 Total Patients Enrolled

Media Library

IOV-4001 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05361174 — Phase 1 & 2
Non-Small Cell Lung Cancer Research Study Groups: Cohort 1, Cohort 2
Non-Small Cell Lung Cancer Clinical Trial 2023: IOV-4001 Highlights & Side Effects. Trial Name: NCT05361174 — Phase 1 & 2
IOV-4001 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05361174 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are involved in this clinical experiment?

"The sponsor of this trial, Iovance Biotherapeutics Inc., is seeking to enrol a contingent of 53 patients that meet the study's criteria. These individuals will be recruited from locations such as Memorial Sloan Kettering Cancer Center in New york and University of Louisville in Kentucky."

Answered by AI

Are there still opportunities for enrolment in this clinical trial?

"Affirmative. Clinicaltrials.gov records support that this clinical trial, which was launched on July 20th 2022, is actively recruiting participants. 53 individuals are needed from 3 locations to complete the study."

Answered by AI

What aims is this research endeavor attempting to achieve?

"The primary objective of this study, which will be tracked over a period up to 60 months, is to assess the safety profile of IOV-4001. Secondary endpoints include Disease Control Rate (DCR), Feasibility of IOV-4001 and Overall Survival (OS). Respectively, they measure response rate based on RECIST v1.1 criteria by an investigator, successful manufacturing with no delays or failures, as well as total time from infusion until death due any cause."

Answered by AI

Who else is applying?

What state do they live in?
Kentucky
New York
How old are they?
65+
18 - 65
What site did they apply to?
University of Louisville
What portion of applicants met pre-screening criteria?
Met criteria
~22 spots leftby Jun 2025